System and method for anchoring stomach implant

ABSTRACT

A gastric implant system includes a gastric implant such as a restrictive pouch or a gastric balloon, an anchor passable through the mouth and stomach and further through the stomach wall into engageable with abdominal wall tissue. When the anchor is engaged to abdominal wall tissue, the stomach wall and abdominal wall are brought into contact with one another such that a proximal portion of the anchor extends into the stomach interior while a distal portion of the anchor remains engaged to the abdominal wall. A locking element coupled to the proximal section of the anchor is used to maintain contact between the stomach wall and abdominal wall. The gastric implant is advanced through the oral cavity into the stomach and is coupled to the anchor.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/844,823, filed Sep. 15, 2006.

TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to the field of systems andmethods for performing endoscopic surgery, and specifically to systemsand methods for endoscopic anchoring of implants within the stomach.

BACKGROUND

Several of Applicant's prior applications, including WO 2005/037152,U.S. Pat. No. 6,675,809, and U.S. application Ser. No. 11/439,461, FiledMay 23, 2006, Attorney Docket BARO 910 (each of which is incorporatedherein by reference in its entirety) describe methods according to whichmedical implants are coupled to tissue within the stomach. According tothese applications, devices for inducing weight loss (e.g. byrestricting and/or obstructing flow of food into the stomach, and/or byoccupying a portion of the stomach volume and/or or by limitingabsorption of nutrients by the stomach and/or small intestine) may becoupled to the stomach tissue, or to tissue tunnels or plications formedfrom stomach tissue.

Other types of implants may be coupled to stomach tissue, plications orother tissue structures for a variety of purposes. These implantsinclude, but are not limited to gastric space occupiers, prostheticvalves for the treatment of gastro-esophageal reflux disease, gastricstimulators, pH monitors and drug eluting devices that release drugs,biologics or cells into the stomach or elsewhere in the GI tract. Suchdrug eluting devices might include those which release leptin (a hormonewhich creates feelings of satiety), Ghrelin (a hormone which createsfeelings of hunger), octreotide (which reduces Ghrelin levels and thusreduces hunger), Insulin, chemotherapeutic agents, natural biologics(e.g. growth factor, cytokines) which aid in post surgery trauma,ulcers, lacerations etc. Still other implants might be of a type whichmight provide a platform to which specific cell types can adhere, growand provide biologically-active gene products to the GI tract, and/or aplatform for radiation sources that can provide a local source ofradiation for therapeutic purposes, or provide a platform wherebydiagnostic ligands are immobilized and used to sample the GI tract forevidence of specific normal or pathological conditions, or provide ananchor point for imaging the GI tract via cameras and other imagecollecting devices.

The present application describes a new system and method for retainingimplants within the stomach. According to the disclosed and illustratedprocedure, an anchor is passed endoscopically from within the stomachthrough the stomach wall and is embedded in the tissue of the abdominalwall. The anchor holds the stomach wall and abdominal wall in contactwith one another. Bonding occurs between the stomach wall and abdominalwall, creating a reinforced tissue region surrounding the anchor. Animplant is coupled to the anchor. Although the implant experiencessignificant forces due to movement of the stomach and passage of foodand liquid through the stomach, the anchor attachment is sufficientlystrong to retain the implant without unintended detachment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-5 are a sequence of schematic views showing a portion of astomach wall and a portion of an abdominal wall, in which:

FIG. 1 illustrates endoscopic implantation of an anchor through thestomach wall and into the abdominal wall.

FIG. 2 illustrates the step of locking the abdominal wall and stomachwall in contact with one another.

FIG. 3 illustrates the step of coupling an implant to the anchor.

FIGS. 4 and 5 illustrate the steps of deploying the implant to itsexpanded state, removing the spacer and adjusting the orifice size ofthe implant.

DETAILED DESCRIPTION

A method of implanting a gastric implant will be described in connectionwith FIGS. 1-5. The method will be described in the context of arestrictive device implantable within the stomach to restrict the flowof food into the stomach, although any other gastric implant including,but not limited to, those listed above may utilize a similar procedure.

At the start of the procedure, the stomach is preferably insufflated toprovide working space within the stomach and to move the stomach wallcloser to the abdominal wall. A flexible endoscope 10 is passed throughthe mouth and esophagus into the stomach. Under endoscopicvisualization, the stomach is palpated until a desired location for ananchor is located. This step may be performed in a manner similar toknown steps for locating a position for a percutaneous gastronomydevice.

An anchor deployment catheter 12 is passed into the stomach via theesophagus and advanced to an area of the stomach wall near the targetanchor site. Disposed within the anchor deployment catheter 12 is ananchor 14 having a distal end that is compressed within the catheter 12but expandable once released from the deployment catheter 12. In oneexample shown in the drawings, the anchor may have a “treble hook” darttype configuration with an elongate body 16 and laterally extendingbarbs 18 similar to those found on a fishing lure. A tether 20 isconnected to the elongate body 16 and extends through the catheter 20.

The catheter 12 is positioned with its distal end in contact with thestomach wall, and the anchor 14 is driven from the stomach through thestomach wall and into the abdominal wall, embedding the anchor in theabdominal wall. The anchor may be driven by fluid or gas pressuredelivered to the anchor, or using a mandrel coupled to the anchor.Alternatively, the anchor may be compressed within a hollow needle thatis advanced through the stomach wall and abdominal wall, and thenreleased from the hollow needle once the needle is positioned within theabdominal fascia.

When the anchor exits the catheter 12, the barbs 18 expand to theirextended positions, causing the anchor to engage with the surroundingtissue. At least a portion of the elongate body 16 remains within thestomach. With tension applied to the tether, a spacer 22 threaded ontothe tether 20 is advanced into contact with the stomach wall to impartsufficient pressure against the stomach wall to draw the stomach walland abdominal wall in contact with one another. A locking button 24,also threaded onto the tether, is advanced behind the spacer 22 andlocked against the body 16 or the tether to maintain the position of thespacer 22 and to retain contact between the stomach wall and abdominalwall. Locking features for this purpose may include teeth 25 on the body16 or tether and corresponding engaging features on the locking button(e.g. similar to a “zip-tie” arrangement). The catheter 12 is removed,leaving the anchor 14, tether 20, spacer 22 and locking button 24 inplace as shown in FIG. 2.

Next, an implantation catheter 26 for a restrictive device is advancedover the tether 20 while tension is maintained on the tether. Inside theimplantation catheter 26 is a tubular restrictive device 28 in acompressed position. The restrictive device 28 may be a self-expandabledevice retained in the compressed position by a tear-away sheath orbiodegradable/absorbable sheath, or it may be one requiring activeexpansion using a balloon or other expandable device positioned withinits lumen.

The restrictive device 28 is anchored to the locking button 24,preferably without deploying the restrictive device 28 to its expandedposition. Delaying expansion of the restrictive device 28 is preferredbecause it allows the anchor attachment to heal and strengthen before itis subjected to the increased stresses imparted as a result of foodflowing through the restrictive device. The implantation catheter 26 iswithdrawn from the body and the tether 20 is cut or removed from theanchor.

After an appropriate healing time, which may be on the order of fivedays, flexible endoscope 10 is advanced back into the stomach.Associated instruments are used to remove the spacer 22, leaving a gapbetween the locking button 24 and the stomach wall as shown in FIG. 4.Removing the spacer 22 minimizes the likelihood or erosion of thestomach wall by the spacer. In one embodiment, the spacer might be havea thickness of approximately 3 cm or more, thus leaving a gap of atleast 3 centimeters between the locking button 24 and the stomach wallupon removal of the spacer. The restrictive device 28 is deployed to itsexpanded position as shown in FIG. 5. The orifice size (e.g. thecross-sectional area of the proximal or distal orifice 32 and/or lumen)of the restrictive device 28 is adjusted as needed to provide a desiredamount of restriction sufficient to lead to an appropriate weight lossfor the patient. Some methods for controlling the orifice size of therestrictor are disclosed in Applicant's U.S. Application 2004-0158331,which is incorporated herein by reference. The restrictive device 28 mayinclude one or more stabilizing bars/struts 30 to maintain stability ofthe device within the stomach and to keep the proximal orifice of theimplant oriented towards the esophagus for receipt of ingested food.

The disclosed system can be packaged with instructions for useinstructing the user to use the system according to methods disclosedherein.

It should be recognized that a number of variations of theabove-identified embodiments will be obvious to one of ordinary skill inthe art in view of the foregoing description. Accordingly, the inventionis not to be limited by those specific embodiments and methods of thepresent invention shown and described herein. Rather, the scope of theinvention is to be defined by the following claims and theirequivalents.

All patents and applications referred to herein, including for purposesof priority, are incorporated herein by reference.

1. A method of anchoring a stomach implant, comprising the steps of:introducing an anchor transorally into a stomach; passing the anchorthrough a wall of the stomach and engaging the anchor to an abdominalwall, a portion of the anchor remaining within the stomach; positioninga stomach implant within the stomach; and coupling the stomach implantto the portion of the anchor within the stomach.
 2. The method of claim1, further including positioning the stomach wall and abdominal wallinto contact with one another.
 3. The method of claim 2, furtherincluding retaining contact between the stomach wall and abdominal wallusing an element on the portion of the anchor within the stomach.
 4. Themethod of claim 2, further including allowing tissue growth to occurbetween the stomach wall and abdominal wall.
 5. The method of claim 4,wherein the stomach implant is coupled to the anchor after allowingtissue growth to occur.
 6. The method of claim 1, wherein passing theanchor includes piercing the stomach wall using the anchor.
 7. Themethod of claim 1, wherein the method includes positioning the anchorwithin a hollow needle, and wherein passing the anchor includes piercingthe stomach wall using the hollow needle.
 8. The method of claim 1,wherein engaging the anchor to the abdominal wall includes engaging theanchor and fascia of the abdominal wall.
 9. The method of claim 1,wherein positioning a stomach implant includes positioning a flowrestrictive device.
 10. The method of claim 1, wherein positioning astomach implant includes positioning a gastric space occupier.
 11. Agastric implant system, comprising: a cannula extendable through a mouthinto a stomach; an anchor; a gastric implant; and instructions for useinstructing the user to extend the cannula through a mouth in to astomach, pass an anchor through the cannula and through a stomach walland to engage the anchor to an abdominal wall with a portion of theanchor extending into the stomach, and to couple the gastric implant tothe portion of the implant extending into the stomach.
 12. The gastricimplant system of claim 11, wherein the gastric implant is a restrictiveorifice for treatment of obesity.
 13. The gastric implant system ofclaim 11, wherein the gastric implant is an obstructive orifice fortreatment of obesity.
 14. The gastric implant system of claim 11,wherein the anchor includes a lock, and wherein the instructions for useinclude instructions to bring the stomach wall into contact with theabdominal wall, and engage the lock within the stomach to maintaincontact between the stomach wall and the abdominal wall.
 15. The gastricimplant system of claim 14, wherein the anchor includes an distal tissueengaging element and a proximal portion proportioned to extend through astomach wall and into a stomach when the distal portion is engaged withabdominal wall tissue, and wherein the lock includes a collar slidableon the proximal portion into abutment with stomach wall tissue andlockable to the proximal portion to retain the collar position inabutment with the stomach wall.
 16. The gastric implant of claim 11,further including a tether coupled to the anchor, the tetherproportioned to extend from the proximal section through the esophagusand stomach and out of the oral cavity when the anchor is engaged withabdominal wall tissue.
 17. The gastric implant of claim 15, wherein thegastric implant is attachable to the collar.
 18. The gastric implant ofclaim 11, further including a detachable spacer between the collar andthe tissue engaging element.
 19. A gastric implant system including: agastric implant; an anchor having a distal portion engageable withabdominal wall tissue within a living body, and a proximal sectionproportioned to extend from the distal portion, through a stomach walland into a stomach when the distal portion is engaged with abdominalwall tissue; and a locking element coupled to the proximal section ofthe anchor, the locking element having an unlocked position in which thelocking element is moveable relative to the anchor into a position inabutment with an interior surface of a stomach wall, and a lockedposition in which the locking element engages a portion of the anchor.20. The implant system of claim 19, wherein the gastric implant is arestrictive implant for treating obesity.
 21. The implant system ofclaim 20, wherein the gastric implant is an obstructive implant fortreating obesity.
 22. The implant system of claim 19, wherein the distalportion of the anchor includes an expandable tip section.
 23. Theimplant system of claim 19, further including a tether coupled to theproximal section, the tether proportioned to extend from the proximalsection through the esophagus and stomach and out of the oral cavitywhen the anchor is engaged with abdominal wall tissue.
 24. The implantsystem of claim 19, wherein the proximal section includes an elongatemember and wherein the locking element includes a collar slidable on theelongate member.
 25. The implant system of claim 24, wherein the collaris lockable to features on the elongate member.